Phase 1 trial of autologous bone marrow mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis.
Phase 1 trial of autologous bone marrow mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis.
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发表时间：
2007-10
影响因子：
2.1
通讯作者：
M. Mohamadnejad;K. Alimoghaddam;M. Mohyeddin-Bonab;M. Bagheri;M. Bashtar;H. Ghanaati;H. Baharvand;A. Ghavamzadeh;R. Malekzadeh
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文献类型：
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作者：
M. Mohamadnejad;K. Alimoghaddam;M. Mohyeddin-Bonab;M. Bagheri;M. Bashtar;H. Ghanaati;H. Baharvand;A. Ghavamzadeh;R. Malekzadeh
背景失代偿期肝硬化的标准治疗是肝移植。然而，它有几个局限性。最近的动物研究表明，骨髓干细胞移植可以导致肝纤维化的消退。本研究的目的是确定失代偿期肝硬化患者自体骨髓间充质干细胞移植的安全性和可行性。方法在这项1期试验中，纳入了4例失代偿期肝硬化患者。抽取骨髓，培养间充质干细胞，并通过外周静脉输注平均31.73 × 10（6）个间充质干细胞。主要结果是评估工作的安全性和可行性。次要结果是评估终末期肝病评分模型的变化和患者的生活质量。结果随访期间患者无不良反应。随访结束时，患者1和4的终末期肝病模型评分分别提高了4分和3分。此外，所有4名患者的生活质量在随访结束时均有所改善。使用SF-36问卷，平均身体成分量表从31.44增加到65.19，平均心理成分量表从36.32增加到65.55。结论间充质干细胞移植治疗失代偿期肝硬化是可行且安全的。
BACKGROUND The standard treatment for decompensated liver cirrhosis is liver transplantation. However, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The objective of this study was to determine the safety and feasibility of autologous bone marrow-mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis. METHODS In this phase 1 trial, four patients with decompensated liver cirrhosis were included. Their bone marrow was aspirated, mesenchymal stem cells were cultured, and a mean 31.73 x 10(6) mesenchymal stem cells were infused through a peripheral vein. Primary outcomes were evaluating the safety and feasibility of the work. Secondary outcomes were evaluating changes in the model for end-stage liver disease score, and the quality of life of the patients. RESULTS There were no side-effects in the patients during follow-up. The model for end-stage liver disease scores of patients 1, and 4 improved by four and three points, respectively by the end of follow-up. Furthermore, the quality of life of all four patients improved by the end of follow-up. Using SF-36 questionnaire, the mean physical component scale increased from 31.44 to 65.19, and the mean mental component scale increased from 36.32 to 65.55. CONCLUSION Mesenchymal stem cell transplantation seems to be feasible and safe in the treatment of decompensated liver cirrhosis.